Principal Mechanical Engineer

4 weeks ago

Alameda, United States Abbott Laboratories Full time

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve peopleâs health. Weâre always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Youâll also have access to:

  • Career development with an international company where you can grow the career you dream of.
  • Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
  • An excellent retirement savings plan with high employer contribution
  • Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelorâs degree.
  • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
  • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

At Abbott, we believe people with diabetes should have the freedom to enjoy active lives. Thatâs why weâre focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. Weâre revolutionizing the way people monitor their glucose levels with our new sensing technology.

The Opportunity
The Principal Mechanical Engineer contributes to resolving significant technical issues and to the development of company objectives. Works independently or in a lead role on the design and development of products. Works independently on identifying and developing new technologies for implementation into new products. Exercises independent judgment in identifying, recommending and implementing significant and/or complex new design improvements to meet new product development and regulatory requirements.  May lead technical teams in the accomplishment of mechanical engineering activities. Develops networks involving cross functional/cross departmental groups as well as communication to senior management.
 
What You'll Work On

  • Design, Development and execution of new medical devices, processes, equipment, materials, verification and validation Implement approved Design Control procedures for development in accordance with FDA guidelines

  • Works in the development of significant design specifications, FMEAs, DOEs, verification and validation protocols.

  • Communicates effectively and participates on cross functional development teams.

  • Participates in technical design reviews of products and design requirements document.

  • Writing, submittal, and approval of Engineering Changes, as required.

  • May review and approve ECs.

  • Act as independent reviewer on programs in which not directly involved.

  • Responsible for utilizing and maintaining the effectiveness of the quality system.

  • Ensures that products meet all applicable standards.

  • Responsible for compliance with applicable Corporate and Divisional Policies.

  • Design, build and test prototypes to evaluate mechanical product design and ability to identify potential design challenges and drive technical decisions.

  • Develop and validate test fixtures, test methods, and inspection methods. Independently create test methods and execute testing to verify new designs and/or changes to existing designs. Present test plans to broader audience.

  • Produce and review design drawings and specification documents.

  • Perform complex engineering calculations and relate results to controlled tests, including statistical analysis, tolerance analysis.

  • Document and run design verification and validation testing which will be submitted to the FDA and other regulatory bodies.

  • Work closely with outside vendors and manage complex projects with them.

  • Conduct formal root cause investigations to identify potential design issues and drive technical decisions.

  • Use statistical techniques to facilitate decision making and to draw conclusions from available data.

  • Create product requirements and design specifications.

 
Required Qualifications

  • Bachelor's degree in mechanical engineering or equivalent engineering or scientific discipline. Master's Degree preferred.

  • Minimum 10 years relevant experience.

  • Minimum 5 yearsâ experience working with Solid Works

  • Experience creating engineering drawings and design specifications using ASME Y14.5

  • Some FEA experience using Ansys or SolidWorks is required to support design optimization. Ansys experience is highly desirable but not necessary if SolidWorks simulation experience is present.

  • Must have prior experience with Tolerance analysis and GDT.

  • Must be experienced in Injection Molded Plastics design.

  • Sound fundamentals in Solid mechanics and strength of materials is a must.

  • Must have good knowledge of general engineering principles. Strong technical experience in mechanical engineering discipline with excellent written and verbal communication skills is essential. 

  • Experience working in cross functional team environments is required.

Preferred Qualifications

  • Experience relevant to the responsibilities listed above.

  • Mechanism and structural dynamic design experience is highly desirable

  • Some experience in engineering management or technical leadership desirable.    

  • Familiarity with regulations for medical device development, (ISO15197, ISO134851, ISO13485, FDA) desired but not necessary.

  • Understanding of GxP, ISO and medical device regulations, particularly with respect to the development of new products in a regulated environment

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.



The base pay for this position is $125,700.00 â $251,500.00. In specific locations, the pay range may vary from the range posted.

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